Compliance, Audit and Validation

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Do you know? To rely on each other’s Good Manufacturing Practice (GMP) inspections pertaining to human medicines, the European Union (EU) and the United States (US) have signed a Mutual Recognition Agreement (MRA) in 1998. However, despite a series of actions and progressive discussions, it was never operational. But the talks which began in 2014 led to revision of Annex in 2017.

In December 2018, the United States Food and Drug Administration (US FDA) published the final guidance on Manufacturing Site Change Supplements: Content and Submission. Replacing the 2015 draft guidance, the final guidance clarifies the responsibilities of medical device manufacturers who are willing to change their manufacturing site for an approved device.

The life sciences industry is ever-changing and evolving. It’s the same in the year 2018. A lot of mandatory changes have been made to the regulations, and a lot of guidance documents have been released pertaining to the best Regulatory practices of consumer healthcare, medical devices, pharmaceuticals, which are expected to impact the industry in a positive way.

Life sciences industries are stepping ahead with new initiatives every day to align with the growing Regulatory restrictions put forth by the health authorities. But as the supervisory expectations of agencies are evolving at an increased pace, at times, organizations are finding it challenging to align with all of them on time.

Quality and compliance are the building blocks of safety and efficacy of drugs and devices. They are the pathways for life science organizations to provide a meticulous framework to their businesses. According to a recent survey, over the years, the Regulatory scrutiny has increased across various aspects of the business including clinical operations, data privacy, and sales and marketing.

Over the decades, with the inception of strict Regulatory regimes, life sciences companies have launched numerous medicinal products in the market prioritizing the end user’s safety. But only few have remained popular sustaining the market competition while many fail to break the initial Regulatory barriers because of incompliant practices.

Between 10/1/2015 and 9/30/2016, the United States Food and Drug Administration (USFDA) through its system has issued almost 3905 483s to Biologics (84), Medical Devices (934), Drugs (691), and Food (2196) manufacturers.

The term “regulatory compliance” takes on different definitions depending on the industry it is being applied to. But from an elevated level, compliance is all about incorporating requisite standards that conform to certain requirements and in relation to Regulatory it is nothing but a set of regulations that any given organization must follow to meet specific requirements.

It is drug manufacturers’ responsibility to ensure the drug/device is developed in accordance with compliance and is also used in safe and secured way. When it comes to hazardous drugs (HD), they are obliged to inform the healthcare facilities about the ways to handle them.